Cove Strip, OsteoCove Strip
FDA 510(k) K232668 · SeaSpine Orthopedics Corporation
510(k) numberK232668
Submission
- Device name
- Cove Strip, OsteoCove Strip
- Applicant
- SeaSpine Orthopedics Corporation
Carlsbad, CA, US - Received
- September 1, 2023
- Decision date
- September 27, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQV – Filler, Bone Void, Calcium Compound
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3045
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262230 | Mg OSTEOREVIVE;Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 09/11/2026SE |
| K260364 | Device 300419 StripMQV · Traditional | Geistlich Pharma AG | 06/02/2026SE |
| K252797 | JAZBI Resorbable Bone Void FillerMQV · Traditional | Sdip Innovations Pty, Ltd. | 05/26/2026SE |
| K261008 | Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip; Vitoss® BiModal Bioactive…MQV · Special | Stryker Spine | 04/24/2026SE |
| K253524 | Adaptos®Fuse Bone GraftMQV · Traditional | Biomendex OY | 02/17/2026SE |
| K253147 | FIBERGRAFT BG Putty GPS Bone Graft Substitute FIBERGRAFT BG Putty Bone Graft…MQV · Special | Prosidyan, Inc. | 10/22/2025SE |
| K251522 | Mg OSTEOINJECT; Mg OSTEOREVIVE; Mg OSTEOCRETEMQV · Traditional | Bone Solutions, Inc. | 10/13/2025SE |
| K252085 | Allomatrix (Allomatrix Injectable Putty; Allomatrix C; Allomatrix DR; Allomatrix Custom)MQV · Traditional | Wright Medical Technology, Inc. (Stryker… | 09/30/2025SE |
| K251556 | Device 300423 GranulesMQV · Traditional | Geistlich Pharma AG | 07/17/2025SE |
| K251720 | OsteoFlo HydroFiberMQV · Special | SurGenTec, LLC | 07/02/2025SE |
More from SurGenTec, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | 07/01/2026SE |
| K250908 | Virata Spinal Fixation SystemNKB · Traditional | 06/18/2025SE |
| K243659 | FLASH Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsOLO · Traditional | 04/02/2025SE |
| K242273 | Cove Putty, OsteoCove PuttyMQV · Traditional | 09/25/2024SE |
| K241466 | Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…MAX · Special | 06/20/2024SE |
| K240566 | Reef L Interbody System; WaveForm L Interbody SystemMAX · Traditional | 04/26/2024SE |
| K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…NKB · Traditional | 04/19/2024SE |
| K233694 | Meridian Interbody System; WaveForm A Interbody SystemMAX · Traditional | 01/12/2024SE |
| K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody SystemOVE · Traditional | 11/28/2023SE |
| K231030 | Cove Putty, OsteoCove PuttyMQV · Traditional | 09/14/2023SE |
Questions and answers
When was Cove Strip, OsteoCove Strip cleared by the FDA?
Cove Strip, OsteoCove Strip (K232668) received a 510(k) decision of Substantially Equivalent on September 27, 2023, 26 days after the submission was received.
What is the product code of K232668?
The FDA product code is MQV – Filler, Bone Void, Calcium Compound, a Class II (moderate risk) device regulated under 21 CFR 888.3045.